GMP DOCUMENTATION CHANGE CONTROLS DEVIATIONS CAPA ETC.
REVIEW OF URS IQ OQ AND PQ DOCUMENTS FOR EQUIPMENT AND FACILITY.
INVENTORY CONTROL OF CRITICAL SPARES FOR EQUIPMENTS.
Experience
12 to 14 Years
Industry
Pharma / Biotech / Life Science
Functional Area
HR / Admin / PM / IR / Training
•Responsible for overseeing and directing all the aspects of Engineering to ensure internal customer’s requirements are fulfilled.
•Responsible for overseeing below mentioned activities and compliance of the same:
•Operation of all utilities, HVAC
•Preventive Maintenance & Calibration
•Breakdown Maintenance
•Responsible for supporting production activities by minimizing machine downtime due to breakdowns.
•Responsible for review of engineering SOPs.
•Responsible for GMP documentation, Change controls, Deviations, CAPA etc.
•Review of URS, IQ, OQ and PQ documents for equipment and facility.
•Inventory control of critical spares for equipments.
•Identifying and execution of energy conservation initiatives.
•*Ensuring closure of Self inspection points on time.
•To ensure optimum utilization of all resources including people and energy.
•Focus on innovation and continuous process improvement towards productivity and cost optimization.
•To prepare operational and capital expenditure budget, and monitor the same after approval.
•To lead the audits as a representative of Engineering department and comply to audit observations.
•To coordinate with Manufacturing, QA, QC, WH, SCM, PD, HR and EHS for engineering related activities.
•To implement improvement and expansion projects.